Senior Director, Gene Therapy Operations; Apheresis

Role Summary

Senior Director, Gene Therapy Operations (Apheresis) leads the Gene Therapy Operations, Apheresis team responsible for treatment center onboarding, training and qualification; patient scheduling and coordination for apheresis and drug product delivery; cell collection optimization support; and drug product storage, thawing, and administration support. This role defines strategy, builds the team, and leads treatment center activation and patient coordination to drive commercial launch readiness for Beam’s lead asset.

• Develop and mentor a high-performing Gene Therapy Operations, Apheresis team focused on delivering an excellent patient and stakeholder experience from scheduling through infusion.
• Develop and execute strategic initiatives and processes for treatment center qualification, training, and ongoing support for patient coordination, scheduling, communication, cell collection support, and drug product infusion support.
• Drive workflow and training development: design training to qualify apheresis and treatment centers, lead activation and certification processes, and provide ongoing operational oversight post-activation.
• Quality and compliance oversight: ensure regulatory standards (FACT, AABB) are met, manage quality records (deviations, CAPAs, change controls), and oversee end-to-end processes for patient apheresis and product delivery; ensure chain of custody and assist in ISBT-128 ST-018 implementation as needed.
• Partner with Quality and Patient Operations to build a robust treatment center network, including center selection, qualification, training, and ongoing support; lead field team providing onsite support.
• Provide Apheresis expertise to support internal activities and external-facing training development.
• Create and conduct Apheresis and Cell Therapy lab onboarding, assessments, training, and collection support as needed.
• Build a metrics program to drive data collection and analysis for optimizing collection procedures, efficiency, and quality.
• Identify, share, and adopt best practices cross-functionally and across centers; champion industry working group initiatives to improve the cell and gene therapy treatment experience for patients.
• Collaborate with other functions to maintain Chain of Identity and Chain of Custody throughout the patient journey.

• Bachelor's degree or combination of education and experience; advanced degree preferred (e.g., MBA, RN, MPH).
• Minimum 10+ years (18+ years preferred) of healthcare or related experience, with significant biotech/cell and gene therapy experience.
• Strong direct apheresis experience within the last five years.
• Preference for experience in Sickle Cell Disease and autologous cell and gene therapy.
• Qualification in Apheresis (QIA) certification preferred.
• Ability to work independently with limited supervision; thrives in a fast-paced, matrixed environment.
• Detail-oriented with ability to assess data and communicate objectives clearly.
• Experience in commercial gene or cell therapy is highly preferred.
• Good knowledge of GCPs, GMPs, AABB, FACT/JACIE, FDA, EMEA, MHRA regulations.
• Effective teaching, training, planning, and problem-solving abilities.
• Willingness to travel domestically (approximately 30–50%).
• Strong teamwork, patient-focused mindset, and solution orientation; excellent listening, communication, and interpersonal skills.
• Excellent people management skills with a track record of developing talent and organizational capability.
• A passion for addressing unmet medical needs of patients.

• Bachelor's degree required; advanced degree preferred (e.g., MBA, RN, MPH).

• Travel domestically approximately 30–50% of the time.